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临床试验/NCT03496610
NCT03496610已完成4 期

Intraoperative Surgical Wound Infiltration vs Quadratus Lumborum (QL) Block for Post-operative Pain Control After Nephrectomy in Living Donor Kidney Transplant Patients

Duke University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年1月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
44
试验地点
1
主要终点
Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time)

研究概览

简要总结

The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection technique (also called a "nerve block") that numbs the nerves going to the abdominal area improve pain control after surgery compared to administration of local anesthetic directly to the surgical incision. The QL block technique uses a numbing solution (local anesthetics) that is injected next to nerves located along muscles in the back to reduce pain. This block will not affect movement in the leg and/or make the legs weak. Some institutions, including Duke, use the QL block for patients having various abdominal surgeries, with the hope of providing good pain relief combined with improved mobility after surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking
  • ASA 1-2 patients undergoing living donor nephrectomy

排除标准

  • ASA 3 or 5
  • Diagnosis of chronic pain
  • Daily chronic opioid use (over 3 months of continuous opioid use)
  • Inability to communicate pain scores or need for analgesia
  • Infection at the site of block placement
  • Pregnant women (as determined by standard of care day-of surgery urine bHCG)
  • Intolerance/allergy to local anesthetics
  • Weight <50 kg
  • Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
  • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

研究组 & 干预措施

Quadratus Lumborum (QL) Block

Active Comparator

Patients will receive a bilateral ultrasound guided QL block by the anesthesia team.

干预措施: QL Block (Procedure)

Surgical wound infiltration

Active Comparator

Patients will receive 266 mg of liposomal bupivacaine mixed with 50 mg non-liposomal bupivacaine infiltrated into the wound by the surgeon.

干预措施: Liposomal Bupivicaine (Drug)

结局指标

主要结局

Opioid Consumption in Oral Morphine Milliequivalents for the First 24 Hours After Surgery (Defined as 24 Hours After the Anesthesia End Time)

时间窗: 24 hours postoperatively

次要结局

  • Self-reported Numeric Pain Scores on Postoperative Day Seven(Postoperative day 7)
  • Self-reported Ability to Walk for 15 Minutes Without Any Difficulty Within the First Postoperative Week(First seven days postoperatively)
  • Worst Bloating Severity in the First Postoperative Week(First seven days postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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